Customizable instrument

ABSTRACT

Methods and apparatus that mix a plurality of individual capture reagents for diagnostic assays are described herein. In an embodiment, a system for optically analyzing a patient sample includes an automated immunochemistry analyzer storing a plurality of capture reagents and a plurality of paramagnetic particles, a user interface configured to allow a selection of a combination of two or more of the capture reagents, and a logic implementer configured to cause the automated immunochemistry analyzer to (i) mix together each capture reagent of the combination of two or more of the capture reagents; (ii) bind the mixture of the combination of two or more of the capture reagents to the paramagnetic particles; (iii) bind the patient sample to the bound mixture of the combination of two or more of the capture reagents; and (iv) optically analyze the patient sample.

PRIORITY CLAIM

This application is a continuation application of U.S. patentapplication Ser. No. 15/745,397, filed Jan. 16, 2018, which is anational phase entry of PCT/US2016/042101, filed Jul. 13, 2016, whichclaims the benefit of U.S. provisional patent application No.62/192,989, filed Jul. 15, 2015, and U.S. provisional patent applicationNo. 62/214,740, filed Sep. 4, 2015, the entire disclosures each of whichis incorporated herein by reference.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to methods and apparatuses forperforming diagnostic assays, and more specifically to methods andapparatus that mix a plurality of individual capture reagents for thediagnostic assays.

BACKGROUND OF THE DISCLOSURE

Many immunochemistry analysis systems require that analyte molecules ina patient's biological sample (e.g. serum or plasma) attach toparamagnetic particles. To bind analyte molecules of interest to theparamagnetic particles, a capture reagent is first bound to theparamagnetic particles, and then the patient sample is bound to thecapture reagent. The analyses performed by such systems, however, arerelatively slow and inefficient because the systems do not provide thecapability for a user to customize a mixture of multiple capturereagents and therefore optimize the analysis of the patient sample fordifferent types of analyte molecules of interest.

SUMMARY OF THE DISCLOSURE

Described herein are methods and apparatus that mix a plurality ofindividual capture reagents for diagnostic assays so that the analysisof a patient sample can be optimized for different types of analytemolecules of interest.

Thus, disclosed herein is a system for optically analyzing a patientsample for a plurality of allergens, the system comprising: an automatedimmunochemistry analyzer configured to store a plurality of capturereagents and a plurality of paramagnetic particles; a user interfaceconfigured to allow a selection of a combination of two or more capturereagents from the plurality of capture reagents; and a logic implementerconfigured to cause the automated immunochemistry analyzer to (i) mixtogether each capture reagent of the combination of two or more capturereagents, (ii) bind the mixture of the combination of two or morecapture reagents to the paramagnetic particles, (iii) bind analytemolecules from the patient sample to the bound mixture of thecombination of two or more capture reagents, and (iv) optically analyzethe bound analyte molecules from the patient sample.

In certain embodiments, the logic implementer is configured to limit thenumber of capture reagents that the user interface allows for selection.In other embodiments, the logic implementer is configured to limit thenumber of capture reagents that the user interface allows for selectionbased on the availability of the capture reagents within the automatedimmunochemistry analyzer. In yet other embodiments, the logicimplementer is configured to adjust the number of capture reagents thatthe user interface allows for selection as a selection is being made.

In other embodiments, the logic implementer is configured to store aplurality of preprogrammed combinations of two or more capture reagentsfor selection using the user interface. In yet other embodiments, theplurality of preprogrammed combinations are sorted by type of symptomexhibited by the patient. In other embodiments, the selection of thecombination of two or more capture reagents is made by individuallyselecting each of the capture reagents in the combination. In yet otherembodiments, the logic implementer is configured to cause the automatedimmunochemistry analyzer to perform additional analysis using at leastone of the two or more capture reagents if a test using the combinationof two or more capture reagents returns a positive result.

Also disclosed herein is a method of optically analyzing a patientsample for a plurality of allergens, the method comprising: selecting acombination of two or more capture reagents from a plurality ofselectable capture reagents; adding each capture reagent of thecombination of two or more capture reagents to a container containingparamagnetic particles; binding the combination of two or more capturereagents to the paramagnetic particles; binding analyte molecules fromthe patient sample to the combination of two or more capture reagents;and optically analyzing the bound analyte molecules from the patientsample.

In certain embodiments, the method includes narrowing the number ofcapture reagents that are available for selection. In other embodiments,selecting from the plurality of selectable capture reagents includesselecting from a plurality of preprogrammed combinations of two or morecapture reagents. In yet other embodiments, selecting from the pluralityof selectable capture reagents includes individually selecting eachcapture reagent from the plurality of selectable capture reagents. Inyet further embodiments, the method includes performing additionaloptical analysis using at least one of the two or more capture reagentsfrom the combination if a test using the combination of two or morecapture reagents returns a positive result.

Also disclosed herein is a system for optically analyzing a patientsample for a plurality of allergens, the system comprising: a pluralityof capture reagents; a plurality of paramagnetic particles; a selectionmodule that allows a selection of a combination of two or more capturereagents from the plurality of capture reagents; a mixing module that(i) mixes together each capture reagent of the combination of two ormore capture reagents, (ii) binds the mixture of the combination of twoor more capture reagents to the paramagnetic particles, and (iii) bindsanalyte molecules from the patient sample to the bound mixture of thecombination of two or more capture reagents; an analysis module thatoptically analyzes the bound analyte molecules from the patient samplefor one or more positive or negative result; and a reporting modulewhich reports the one or more positive or negative result determined bythe analysis module.

In certain embodiments, the system includes an inventory tracking modulethat stores locations of the plurality of capture reagents. In otherembodiments, the inventory tracking module communicates the locations ofthe plurality of capture reagents to at least one of: (i) the selectionmodule; (ii) the mixing module; and (iii) the analysis module. In yetanother embodiment, the system includes an inventory replenishmentmodule that replenishes the plurality of capture reagents.

In other embodiments, the analysis module instructs the mixing module tomix a second combination of two or more capture reagents if a test ofthe combination of two or more capture reagents returns a positiveresult. In yet other embodiments, the selection module allows forindividual selection of each capture reagent of the combination of twoor more capture reagents. In yet other embodiments, the selection moduleallows for selection of the combination of two or more capture reagentsfrom a plurality of preprogrammed combinations of two or more capturereagents.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure will now be explained in furtherdetail by way of example only with reference to the accompanyingfigures, in which:

FIG. 1 is a top schematic view of an embodiment of an automatedimmunochemistry analyzer and reagent system according to the presentdisclosure;

FIG. 2 is a schematic illustration of an embodiment of a process forperforming a diagnostic assay according to the present disclosure;

FIG. 3A to 3C illustrate an embodiment of a graphical user interfacethat can be used with the process of FIG. 2;

FIGS. 4A and 4B are schematic illustrations of an embodiment of aprocess for performing a diagnostic assay according to the presentdisclosure;

FIGS. 5A and 5B are schematic illustrations of an embodiment of aprocess for performing a diagnostic assay according to the presentdisclosure;

FIG. 6 is a schematic illustration of an embodiment of a process forperforming a diagnostic assay according to the present disclosure;

FIG. 7 is a schematic illustration of an embodiment of a system that canbe controlled to perform the processes of FIGS. 2 to 6.

DETAILED DESCRIPTION

Before describing in detail the illustrative system and method of thepresent disclosure, it should be understood and appreciated herein thatthe present disclosure relates to methods and apparatus that mix aplurality of individual capture reagents to optimize diagnostic assaysfor different types of analyte molecules of interest. In general, thesystem utilizes common paramagnetic particles, for example, magneticbeads or microparticles that are pulled to the wall of a reactioncuvette by magnets during a washing process so that liquid can beaspirated from the cuvette.

In some embodiments, the present systems are not microfluidics systemswhich may include DNA chips, lab-on-a-chip technology, micro-propulsion,and micro-thermal technologies. In some embodiments, the present systemsinclude immunoanalyzer instruments that can use one or more automatedpipettor, reaction rotors, physically picking up and moving samples andreagents, and combinations thereof.

In the beginning of the process, the paramagnetic particles are coatedwith one or more capture reagent that will eventually bind analytemolecules of interest in the patient's blood sample. After the capturereagents bind to the paramagnetic particles and the cuvettes undergo awashing process, the patient sample, and optionally a diluent if needed,is added to the particles in the reaction cuvette and incubated. Thisallows analytes of interest in the patient's blood sample to bind to theone or more capture reagent that has in turn been bound to the surfaceof a paramagnetic particle.

After the patient sample incubation period, another washing process isperformed to remove any excess or unbound sample. Then, a conjugate anda luminescent label are added to the cuvette. When added to the cuvette,it can be expected that some portion of the conjugate will bind to thecapture reagent/sample complex on the paramagnetic particles after anincubation period. The particles then undergo another wash process toremove any unbound conjugate. Then, a luminescent label is added to thereaction cuvette and incubated for a short period of time to allow thechemiluminescent glow reaction to reach equilibrium. After equilibriumis reached, luminescence and fluorescence readings of the sample can betaken.

FIG. 1 illustrates various components of an embodiment of an automatedimmunochemistry analyzer 1 according to the present disclosure.Automated immunochemistry analyzer 1 can take an analyte sample, createan environment that will allow it to bind to a paramagnetic particle,perform a number of washing steps, and then quantify and normalize theluminescence signal of the analyte sample. This can be accomplishedthrough an automated process that utilizes a vortexer 2, an R1 pipettor4, a reaction rotor 6, an optics pipettor 8, an optics box 10, a multirinse pipettor 12, a reagent rotor 14, a single rinse pipettor 16, asample rotor 18, a sample pipettor 20, an R2 pipettor 22, and a mixedsubstrate container 24.

To better understand the present disclosure, a sample process will beoutlined explaining one possible method the apparatus could utilize toquantify and normalize the luminescence signal of an analyte sample. Inan embodiment, automated immunochemistry analyzer 1 begins by firstdispensing fluorescently labelled paramagnetic particles, or fluo-beads,into a cuvette located within the reaction rotor 6. The fluo-beads canbe initially located in vortexer 2 and transferred to reaction rotor 6by R1 pipettor 4. R1 pipettor 4 can aspirate a desired quantity of thefluo-bead mixture and transfer the aspirated quantity to reaction rotor6 where it is injected into the cuvette of reaction rotor 6. Opticspipettor 8 can then aspirate a test sample from the cuvette of reactionrotor 6 and transfer the test sample to optics box 10, wherefluorescence and luminescence measurements can be recorded.

The fluorescence and luminescence measurements can be taken directlythrough the at least partially transparent optics pipette tip. Theoptics box can include at least one light source and at least onedetector. The light source(s) can project light at the optics pipettetip. Detectors can be placed behind the optics pipette tip therebycapturing light traveling through the optics pipette tip and itscontents or can be placed at other locations in the optics box that cancollect scattered or reflected light. One skilled in the art canenvision various configurations.

The initial recording of the fluorescence and luminescence signal can beused as a baseline measurement for the fluorescence signal that cancorrespond to the initial concentration of fluo-beads in a sample. Afterrecording the measurements, multi rinse pipettor 12 can rinse thecuvettes using a wash buffer.

Next, fluo-beads can be transferred from vortexer 2 to a cuvette inreaction rotor 6 via R1 pipettor 4. R1 pipettor 4 can aspirate one ormore capture reagent from the reagent rotor 14 and inject the one ormore capture reagent into the cuvette located in reaction rotor 6. Afteran incubation period, single rinse pipettor 16 can inject a rinse bufferto stop the capture reagent binding reaction with precise timing. Asubstantial amount of the suspended fluo-bead can then be localized bymagnets within the reaction rotor 6 over a period of time. After themagnets have substantially localized the fluo-beads within the cuvette,multi rinse pipettor 12 can aspirate and dispose of a portion of therinse buffer, leaving a portion of the fluo-beads localized within thecuvette. Multi rinse pipettor 12 can proceed to inject a wash bufferinto the cuvette of reaction rotor 6, resuspending the fluo-beads. Thefluo-beads can again be localized by the magnets within reaction rotor 6to be followed by multi rinse pipettor 12 aspirating and discarding aportion of the sample that was not localized from the cuvette in thereaction rotor 6.

A patient sample can be contained in a sample tube in sample rotor 18.The patient sample can further be partially diluted with a samplediluent. At this point, sample pipettor 20 can aspirate a portion of thepatient sample and inject the patient sample into the cuvette ofreaction rotor 6 to resuspend the fluo-beads. The cuvette containing thepatient sample within the reaction rotor 6 can then incubate the patientsample. In one embodiment, the incubation temperature can be about 37degrees Celsius+/−about 0.2 degree Celsius while the incubation time canbe about 37.75 minutes+/−about 2 minutes. After incubation, multi rinsepipettor 12 can inject the rinse buffer to again resuspend thefluo-beads. Another localization process is performed by reaction rotor6 by allowing the fluo-beads to substantially collect within the cuvettenear the magnets in reaction rotor 6. After the localization of thefluo-beads, multi rinse pipettor 12 can aspirate and discard a portionof the fluid within the cuvette of reaction rotor 6 that was notlocalized during the localization process.

Multiple rinse cycles can then be performed on the sample within thecuvette of reaction rotor 6. The rinse cycles can be performed usingmulti rinse pipettor 12 to inject a wash buffer into the cuvette toresuspend the fluo-beads. Another localization step can allow thefluo-beads to collect within the cuvette by the magnets within reactionrotor 6. After about a 90 second fluo-beads collection period, multirinse pipettor 12 can aspirate and discard a portion of the wash buffer,leaving a substantial portion of the fluo-beads within the cuvette ofthe reaction rotor 6. Another rinse cycle can then occur using multirinse pipettor 12 to again inject wash buffer into the cuvette and allowthe fluo-beads to resuspend. Another fluo-bead localization process canutilize the magnets within the reaction rotor 6 to localize thefluo-beads from the rest of the sample. Finally, the multi rinsepipettor 12 can aspirate a portion of the sample that was not localizedby the localization process.

At this point, R1 pipettor 4 can aspirate a conjugate contained in aconjugate cuvette within reagent rotor 14. R1 pipettor 4 can then injectthe previously aspirated conjugate into the cuvette of the reactionrotor 6. After incubating the cuvette under controlled time andtemperature in reaction rotor 6, multi rinse pipettor 12 can inject arinse buffer into the cuvette in reaction rotor 6. Another fluo-beadlocalization cycle can be performed by allowing magnets within reactionrotor 6 to substantially localize the fluo-beads within the cuvette.Multi rinse pipettor 12 can aspirate and discard a portion of the samplewithin the cuvette that has not been localized during the localizationcycle.

Multiple rinse cycles can be performed on the sample within the cuvetteof reaction rotor 6. Multi rinse pipettor 12 can inject a wash buffer toresuspend the fluo-beads within the cuvette. Another fluo-beadlocalization cycle can localize the fluo-beads by locating the cuvettewithin close proximity to the magnets in reaction rotor 6 over anadequate period of time. After the localization cycle, multi rinsepipettor 12 can aspirate and discard a portion of the sample that wasnot localized during the localization cycle. Another wash cycle can thenoccur by using multi rinse pipettor 12 to inject the wash buffer toresuspend the fluo-beads. Another localization cycle can utilize themagnets within reaction rotor 6 to localize the fluo-beads within thecuvette. After the localization process, multi rinse pipettor 12 canagain aspirate and discard a portion of the sample that was notlocalized during the localization cycle.

At this point, R2 pipettor 22 can aspirate a portion of a firstsubstrate and a second substrate from reagent rotor 14 and inject thesubstrates into the mixed substrate container 24 creating a mixedsubstrate sample. R2 pipettor 22 can then aspirate the mixed substratesample from the mixed substrate container 24 and inject the mixedsubstrate sample into the cuvette of the reaction rotor 6, resuspendingthe fluo-bead with the mixed substrate sample. The sample is thenincubated for a period of time. The sample in the cuvette of reactionrotor 6 can then be aspirated by optics pipettor 8 and placed in opticsbox 10. After optics box 10 makes fluorescence and luminescence opticalobservations, the sample is discarded and the multi rinse pipettorrinses the cuvettes of reaction rotor 6 in preparation for the nexttest.

For the above steps to be possible, a capture reagent must be bound tothe fluo-beads within a cuvette in reaction rotor 6 to create a singlesolid phase that is then combined with a patient sample. In anembodiment of the present disclosure, a user of automatedimmunochemistry analyzer 1 can customize a solid phase on the fly withseveral different capture reagents of the user's choosing. Thiscustomizable feature is advantageous because it improves the efficiencyand timing to test a patient sample for multiple allergens.

In an embodiment, automated immunochemistry analyzer 1 can include agraphical user interface (“GUI”) 30 and a logic implementer 32 that worktogether to allow a user to customize a solid phase. GUI 30 and logicimplementer 32 can accompany or be a part of automated immunochemistryanalyzer 1, or can be located remotely from automated immunochemistryanalyzer 1 and communicate with automated immunochemistry analyzer 1 viaa wireless or wired data connection.

FIG. 2 illustrates a flow chart of a process that uses GUI 30 and logicimplementer 32 to allow a user to create a single solid phase that testsa patient sample for multiple allergens. Beginning at step 40, a userinitiates the process by instructing GUI 30 that the user wishes tocustomize a single solid phase with multiple capture reagents. The usercan instruct GUI 30 to create a single solid phase for a single patientsample or for multiple patient samples. If the user has previouslycustomized solid phases and saved those solid phases to logicimplementer 32, the user can also be presented with the option ofrecalling a previously customized solid phase from a library ofpreprogrammed customized solid phases that automated immunochemistryanalyzer 1 is capable of creating on the fly based on the capturereagents available to automated immunochemistry analyzer 1. If the userwishes to create a newly customized solid phase, logic implementer 32proceeds to steps 42 and 44. If the user wishes to access a library ofpreprogrammed customized solid phases, then the logic implementer 32proceeds to steps 46 and 48.

At step 42, GUI 30 presents the user with a series of options based onthe capture reagents that are available for use within reagent rotor 14.The series of options are provided to GUI 30 by logic implementer 32,which stores information on each of the capture reagents that areavailable for use within reagent rotor 14. The stored information caninclude, for example, the name of the capture reagent, the amount ofcapture reagent currently held by reagent rotor 14, and cross-reactivityinterference information on each capture reagent. The stored informationcan also include a class (e.g., allergy) and subclass (e.g., grass,mold, environmentals, etc.) for each capture reagent. Using the storedinformation, logic implementer 32 can determine every combination ofcapture reagents that can be created by automated immunochemistryanalyzer 1.

Using the class and subclass of each capture reagent, GUI 30 can presentthe user with suggested combinations of capture reagents to test. In anembodiment, GUI 30 presents the user with a list of symptoms, from whichthe user can select one or more symptoms. Based on the selected symptom,GUI 30 can then present the user with a suggested combination of capturereagents. For example, one symptom could be that of an allergic reactionwhen drinking wine. If the user selected this symptom, GUI 30 couldsuggest a combination of capture reagents that test for allergicreactions to grapes, yeast, tartaric acid, and other wine ingredients.Other symptoms could include, for example, symptoms related to differentautoimmune disorders.

The series of options provided to GUI 30 by logic implementer 32 can benarrowed by logic implementer 32 for a variety of reasons. For example,if the user wishes to create a solid phase to test with multiple patientsamples, but reagent rotor 14 does not have enough of a capture reagentstored to create enough solid phase to test each of the samples, logicimplementer 32 can either remove that capture reagent as an option,instruct the user as to the deficiency with the capture reagent, or addmore of the capture reagent to reagent rotor 14.

Logic implementer can also determine whether certain capture reagentscannot be combined with other capture reagents, or can place a limit onthe total number of capture reagents that can be combined. FIGS. 3A to3C illustrate an example embodiment of GUI 30, in which the user ispresented with five possible capture reagents that are stored in reagentrotor 14. Those of ordinary skill in the art will recognize that morethan five capture reagents will be stored in reagent rotor 14 in mostinstances, but the number has been reduced in the present example forsimplicity. In FIG. 3A, the user can click on any one of the fiveindividual capture reagents to add the capture reagent to a combinationsolid phase. In FIG. 3B, the user has chosen to add Capture Reagent A tothe solid phase. When the user makes the selection of Capture Reagent A,however, logic implementer 32 determines that Capture Reagent A andCapture Reagent C cannot be combined, so logic implementer 32 removesCapture Reagent C from the list of remaining options, and CaptureReagent C remains removed from the remaining options unless the userdeselects Capture Reagent A. In FIG. 3C, the user has chosen to mixCapture Reagent D with Capture Reagent A. As before, logic implementer32 then determines that Capture Reagent B is not compatible with CaptureReagent D, so logic implementer 32 removes Capture Reagent B from thelist of remaining options, and Capture Reagent B remains removed fromthe remaining options unless the user deselects Capture Reagent D. In analternative embodiment, logic implementer 32 removes Capture Reagent Bin FIG. 3C because although Capture Reagent B can be compatible withCapture Reagent D, Capture Reagent B is not compatible with thecombination of Capture Reagent A and Capture Reagent D.

Logic implementer 32 can therefore continuously reassess the potentialoptions available to the user as the user makes selections, and updateGUI 30 with new information. In an alternative embodiment to FIGS. 3A to3C, the user can be presented with all five options and the logicimplementer can wait until after the user has selected the desiredcapture reagents to determine if the selected capture reagents arecompatible. Logic implementer 32 can also be programmed to suggestalternative capture reagents to the user if the user chooses acombination that cannot be created by automated immunochemistry analyzer1.

In step 44 of FIG. 2, the user has individually selected each capturereagent to be added to a combination. The user therefore finalizes theselected combination, and logic implementer 32 then determines whereeach of the selected capture reagents is located within reagent rotor14. Logic implementer 32 can then dispense the appropriate amount offluo-beads into a cuvette located within the reaction rotor 6, and thencontrol R1 pipettor 4 and reagent rotor 14 to cause R1 pipettor 4 toaspirate each of the individually selected capture reagents from reagentrotor 14 and inject the capture reagents into the cuvette located inreaction rotor 6.

If the user selects at step 40 to access a library of preprogrammedcustomized solid phases, then the process proceeds from step 40 to step46, where logic implementer 32 provides GUI 30 with a list of previouslystored combinations. In an embodiment, the user at step 44 can save aselected combination to the library for later access by the logicimplementer. Alternatively, the stored combinations can be programmedbefore the user initiates automated immunochemistry analyzer 1, or canbe downloaded to automated immunochemistry analyzer 1 via a wireless orwired data connection. Logic implementer 32 can also narrow theselections from the library that are available for selection by the userbased on, for example, whether the user exhibits a particular symptom,whether a capture reagent of a combination is available to add to amixture at the time of selection, or whether an amount of an availablecapture reagent is enough for the selected test. At step 48, the usermakes a selection from the list provided by logic implementer 32, sothat logic implementer 32 can then dispense the appropriate amount offluo-beads into a cuvette located within the reaction rotor 6, and thencontrol R1 pipettor 4 and reagent rotor 14 to cause R1 pipettor 4 toaspirate each capture reagent of the selected combination from reagentrotor 14 and inject the capture reagents into the cuvette located inreaction rotor 6.

In some embodiments, step 47 and/or 49 can be implemented. If step 47 isimplemented, after a user selects options at step 44, she can thenaccess previously stored lists. This can be in the form of suggestedadditional tests based on previously similar lists or can be a listsuggested by the system as an alternative or addition to what has beenchosen. If step 49 is implemented, after a user access previously storedlists and solid phase form at steps 46 and 48, she can then selectsoptions at step 44. This can allow a user to customize a previouslystored list.

In step 50 of FIG. 2, the combination solid phase is combined with apatient sample and incubated, bound and tested as described above byperforming several wash steps, adding the conjugate and substrate, andthen aspirating the patient sample into optics pipettor 8 so that opticsbox 10 can take fluorescence and luminescence measurements. Asunderstood by those of skill in the art, a positive result determined byoptics box 10 for a mixture of capture reagents indicates a positiveresult for at least one of the capture reagents in the mixture. Forexample, a positive test with respect to a mixture containing CaptureReagent A, Capture Reagent B and Capture Reagent C would indicate apositive test for at least one of Capture Reagent A, Capture Reagent Band Capture Reagent C. In this case, however, it may not be possible todetermine which one or more of Capture Reagent A, Capture Reagent B andCapture Reagent C caused the positive test. On the other hand, anegative result for a mixture of Capture Reagent A, Capture Reagent Band Capture Reagent C conclusively indicates that the patient sample didnot test positive for any one of Capture Reagent A, Capture Reagent Band Capture Reagent C.

Logic implementer 32 can therefore end the test if there is a negativeresult for the optical analysis of the patient sample at step 50. Thatis, if logic implementer 32 has determined that the mixture of capturereagents yielded a negative result at step 50, logic implementer 32 canthen proceed to step 56 and report to the user via GUI 30 or anothermechanism that the patient sample tested negative for each of thecapture reagents in the selected mixture.

If the mixture tested positive at step 50, however, logic implementer 32can proceed to step 52. At step 52, logic implementer attempts todetermine whether the positive result can be attributed to a particularcapture reagent within the mixture, or whether any particular capturereagent in the mixture can be ruled out as causing the positive resultas shown for example at FIG. 6 below. If logic implementer 32 canconclusively determine that each capture reagent of the combinationeither caused the positive result or could not have caused the positiveresult, logic implementer 32 can then proceed to step 56 and report tothe user via GUI 30 or another reporting mechanism the results for eachcapture reagent of the combination.

If logic implementer 32 cannot conclusively determine that any onecapture reagent in the mixture caused the positive result and that therest of the capture reagents in the mixture can be eliminated, logicimplementer 32 proceeds to step 54. At step 54, logic implementer caneither break down the capture reagents into subgroups, or test eachindividual capture reagent separately, depending on how many capturereagents are in the combination or how many capture reagents could haveyielded the positive result. Once logic implementer performs additionaltesting of the capture reagents and determines whether each capturereagent results in a positive or negative test, logic implementer 32 canthen proceed to step 56 and report to the user via GUI 30 or anotherreporting mechanism the results for each capture reagent of thecombination. In an alternative embodiment, logic implementer can skipsteps 52 and 54 and simply report to the user via GUI 30 or anotherreporting mechanism that the patient sample tested positive for at leastone of the capture reagents in the mixture.

FIG. 4A is a flow chart illustrating a simple example of how logicimplementer 32 can perform a test of Capture Reagent A, Capture ReagentB and Capture Reagent C. As illustrated, logic implementer 32 begins atstep 60 a by testing a mixture of Capture Reagent A, Capture Reagent Band Capture Reagent C. If the mixture yields a negative result, thenlogic implementer can conclusively report at step 62 a that the patientsample tested negative for each of Capture Reagent A, Capture Reagent Band Capture Reagent C. If the initial test yields a negative result,only one test is required to report on three different reagents.

If the mixture yields a positive result, then logic implementer at steps64 a, 66 a and 68 a separately tests each of Capture Reagent A, CaptureReagent B and Capture Reagent C. Logic implementer can then report atsteps 70 a, 72 a and 74 a the results for each of Capture Reagent A,Capture Reagent B and Capture Reagent C.

FIG. 4B shows an example of how the testing of FIG. 4A would proceed ifonly Capture Reagent C tested positive for a particular patient sample.At step 60 b, the test yields a positive result for the mixture ofCapture Reagent A, Capture Reagent B and Capture Reagent C. Logicimplementer 32 therefore separately tests each of Capture Reagent A,Capture Reagent B and Capture Reagent C at steps 64 b, 66 b and 68 b,respectively. At steps 64 b and 66 b, logic implementer 32 determinesthat Capture Reagent A and Capture Reagent B yield negative results,which are reported to the user at steps 70 b and 72 b. At step 68 b,logic implementer 32 determines that Capture Reagent C yields a positiveresult, which is reported to the user at step 74 b.

It should be apparent from FIG. 4B that logic implementer 32 ran fourseparate tests (60 b, 64 b, 66 b, 68 b) to determine that the sampletested positive for Capture Reagent C, whereas only three tests would benecessary if each of Capture Reagent A, Capture Reagent B and CaptureReagent C was tested separately from the beginning. It should beunderstood, however, that the tests are being run for hundreds orthousands of samples, and that every negative test of a three reagentmixture requires only one test (versus three individual tests) todetermine that the patient sample tests negatively for each of the threecapture reagents. As the number of patient samples increases, the numberof total tests decreases significantly. For example, if one hundredpatient samples are tested for three different reagents using theexample in FIG. 4A, and half of those tests yield a negative result forall three reagents, then the average number of tests per sample woulddecrease to 2.5 (as opposed to 3 tests per sample if each capturereagent is tested separately) (50*1+50*4=250; 250/100=2.5). Thus, inthis example, the total number of tests run for the one hundred patientsamples is cut from 300 (with individual testing) to 250 (with mixturetesting according to the present disclosure).

In some embodiments described herein, the number of tests run usingmixture testing can be reduced by more than about 5%, more than about10%, more than about 15%, more than about 20%, between about 5% andabout 20%, between about 10% and about 20%, between about 15% and about20%, between about 5% and about 15%, or between about 5% and about 30%.

The reduction of the total number of tests is even more significant asthe number of capture reagents tested is increased. FIG. 5A showsanother example of a more complicated scheme in which logic implementer32 breaks down a ten reagent mixture into subgroups to determine thecause of a positive result. Similar to above, if the ten reagent mixtureyields a negative result, then logic implementer 32 can conclusivelyreport that the patient sample tested negative for each of CaptureReagents A-J. If the ten reagent mixture yields a positive result, thenlogic implementer 32 proceeds to further testing.

In FIG. 5A, logic implementer 32 begins at step 80 a by testing amixture of Capture Reagents A-J. If the mixture yields a negativeresult, then logic implementer 32 can conclusively report at step 82 athat the patient sample tested negative for each of Capture ReagentsA-J. If the initial test yields a negative result, only one test isrequired to report on ten different reagents.

If the test at step 80 yields a positive result, logic implementer 32moves on to steps 84 a and 86 a, where the logic implementer 32 breaksthe ten capture reagents into two subgroups with five reagents in eachgroup. Logic implementer 32 then tests each of the two subgroups, and ifeither subgroup yields a negative test result, logic implementer 32 canrespectively move on to step 88 a or 89 a and report that the fivecapture reagents in the subgroup each yield a negative result. If one orboth of the two subgroups yields a positive result, logic implementer 32can move on to steps 90 a-99 a, where the capture reagents areseparately tested. Logic implementer 32 can then report the results atsteps 100 a-109 a.

FIG. 5B shows an example of how the testing of FIG. 5A would proceed ifonly Capture Reagent C tested positive for a particular patient sample.At step 80 b, the test yields a positive result for the mixture ofCapture Reagents A-J. Logic implementer 32 therefore separates CaptureReagents A-J into a first subgroup with Capture Reagents A-E and asecond subgroup with Capture Reagents F-J, and separately tests thefirst subgroup and the second subgroup at steps 84 b and 86 b,respectively.

At step 86 b, logic implementer 32 determines that the second subgroupwith Capture Reagents F-J yields a negative result. Logic implementer 32can therefore conclusively determine that none of Capture Reagents F-Jcaused the positive result at step 80 b, and logic implementer 32 canreport the negative result for each of Capture Reagents F-J at step 89b.

At step 84 b, logic implementer 32 determines that the first subgroupwith Capture Reagents A-E yields a positive result. Logic implementer 32can then break the first subgroup into additional subgroups or test eachof the capture reagents separately. In the example shown, logicimplementer 32 has tested each the capture reagents in the firstsubgroup separately, and has determined at step 92 b that CaptureReagent C caused the initial positive result at step 80 b. The positiveresult for Capture Reagent C, as well as the negative results for eachof the other capture reagents, are then reported to the user at steps 89b and 100 b-104 b.

In the example of FIG. 5B, logic implementer 32 runs a total of eighttests (80 b, 84 b, 86 b, 90 b, 91 b, 92 b, 93 b, 94 b) to determine thatthe sample tested positive for Capture Reagent C, whereas ten testswould be necessary if each of Capture Reagents A-J was tested separatelyfrom the beginning. In comparison with the example of FIG. 4, FIG. 5demonstrates that as the number of capture reagents in the initialmixture increases, the relative number of tests performed decreases. Inthe example of FIG. 5B, if one hundred patient sample were tested forten different reagents, and half of those tests yielded a positiveresult for one reagent, then the average number of tests per samplewould decrease to 4.5 (as opposed to 10 tests per sample if each capturereagent is tested separately) (50*1+50*8=450; 450/100=4.5). Thus, inthis example, the total number of tests run for the one hundred patientsamples is cut from 1000 (with individual testing) to 450 (with mixturetesting according to the present disclosure).

FIG. 6 shows one example embodiment of how logic implementer 32 caneliminate a capture reagent as having caused a positive test result,without having to retest the particular capture reagent. In FIG. 6,logic implementer 32 initiates two separate tests. At step 120, logicimplementer 32 initiates a test for Symptom A by testing a mixture ofCapture Reagents A and B, and at step 122 logic implementer 32 initiatesa test for Symptom B by testing a mixture of Capture Reagents B, C andD. At step 124, logic implementer determines that the mixture of CaptureReagents A and B yielded a positive result, which could be attributed toCapture Reagent A, Capture Reagent B, or both of Capture Reagents A andB. At step 126, however, logic implementer determines that the mixtureof Capture Reagents B, C and D yielded a negative result, meaning thatthe patient sample tested negative for each of Capture Reagents B, C andD, which logic implementer can report to the user via GUI 30 or anothermechanism at step 128. At step 130, logic implementer combines the testsfor Symptom A and Symptom B, and determines that Capture Reagent B couldnot have caused the positive result for the mixture of Capture ReagentsA and B because the patient sample tested negative for Capture Reagent Band step 126. Logic implementer 32 can therefore report to the user atstep 132 that Capture Reagent A caused the positive result of the testof the mixture of Capture Reagents A and B.

FIG. 7 illustrates an embodiment of a system 210 with a plurality ofoptimization modules that are controlled by logic implementer 32 toperform the above process. In the illustrated embodiment, system 210includes a selection module 220, an inventory tracking module 230, amixing module 240, and analysis module 250, a reporting module 260, acommunications module 270 and an inventory replenishment module 280.Those of ordinary skill in the art will recognize that more or lessmodules can be utilized according to the present disclosure.

Selection module 220 initiates the process illustrated at FIGS. 2 to 5,for example, when a user turns on automated immunochemistry analyzer 1or indicates via GUI 30 that a new test is to be run using automatedimmunochemistry analyzer 1. In an embodiment, selection module 220allows the user to select via GUI 30 one or more patient samples to usefor one or more new tests. The selection of one or more patient samplescan be performed at the initiation or later in the process. In analternative embodiment, patient data can be downloaded to selectionmodule 220 via communications module 270, which can include a wirelessnetwork or a wired connection. In another embodiment, the selection ofone or more patient samples can occur via the downloaded data.

Once the process has been initiated, selection module 220 communicatesto inventory tracking module 230 via communications module 270 that anew test is to be run. Inventory tracking module 230 keeps track of thereagents and/or patient samples that are available for use by automatedimmunochemistry analyzer 1, for example, by accessing stored informationon each of the capture reagents that are available within reagent rotor14 and/or each of the patient samples that are stored in sample rotor18. The stored information can be programmed by a user when new reagentsand/or patient samples are added to automated immunochemistry analyzer1, can be scanned into the system prior to initiation of the test using,for example, a machine-readable data scanner such as a barcode scanner,or can be generated by the inventory tracking module 230 via themachine-readable data scanner at the time that a new test is initiatedby selection module 220. The stored information can include, forexample, the name of the capture reagent, the amount of capture reagentcurrently held by reagent rotor 14, cross-reactivity interferenceinformation on each capture reagent and/or patient identification orblood sample information. The stored information can also include aclass (e.g., allergy) and subclass (e.g., grass, mold, environmentals,etc.) for each capture reagent.

Inventory tracking module 230 can also communicate with an inventoryreplenishment module 280 if one or more reagents are not availablewithin the reagent rotor 14 but are available for use by automatedimmunochemistry analyzer 1. In an embodiment, spare capture reagent canbe stored outside of reagent rotor 14 and accessed or added to reagentrotor 14 when needed.

Once inventory tracking module 230 has surveyed the available inventory,inventory tracking module 230 communicates the available inventory toselection module 220 via communications module 270. Selection module 220then organizes the available inventory and presents the availableinventory to the user via GUI 30. In an embodiment, selection module 220presents the user with a series of options based on the capture reagentsthat are available within reagent rotor 14. The series of options can bea list of available reagents for individual selection. Alternatively,the series of options can be preprogrammed combinations that areavailable to the user based on the individual reagents that areavailable. In an embodiment, the preprogrammed combinations are based ona particular symptom exhibited by the patient. For example, if the userhas previously customized solid phases and saved those solid phases, theuser can be presented with the option of recalling a previouslycustomized solid phase from a library of preprogrammed customized solidphases that the automated immunochemistry analyzer 1 is capable ofcreating on the fly based on the available inventory.

Selection module 220 then allows the user to individually select capturereagents to combine, to select a combination of capture reagents, and/orto select patient samples for testing via GUI 30. The user can also bepresented with the option of saving a selected combination of capturereagents that can be recalled for subsequent tests.

Once a selection of a combination of capture reagents has been made,selection module 220 communicates the selected combination to mixingmodule 240 via communications module 270. Mixing module 140 thenaccesses reagent rotor 14 via R1 pipettor 4 and causes each selectedcapture reagent to be added to a cuvette within reaction rotor 6.

In an embodiment, mixing module 240 communicates with inventory trackingmodule 230 via communications module 270, before the capture reagentsare mixed, to communicate the selected combination to inventory trackingmodule 230. Inventory tracking module 230 then confirms that each of theselected capture reagents is available for use and sends mixing module240 the exact location of each of the selected capture reagents withinreagent rotor 14. If the capture reagents need replenishment byinventory replenishment module 280, then inventory tracking module 230communicates with inventory replenishment module 280 so that the neededcapture reagents are added to reagent rotor 14, and then communicatesthe location of the newly added capture reagents to mixing module 240.Once mixing module 240 knows the location of each individual capturereagent of the selected combination, mixing module 240 can cause R1pipettor 4 to separately aspirate each capture reagent and inject eachcapture reagent into a cuvette in reaction rotor 6. In an alternativeembodiment, the location of each capture reagent of the selectedcombination in reagent rotor 14 can be communicated to mixing module 240by selection module 220 without mixing module 240 having to communicatewith inventory tracking module 230.

Once the selected capture reagents have been mixed and incubated so thatthe analytes of interest in the patient's blood sample are bound to thecapture reagent that has in turn been bound to the surface of aparamagnetic particle, analysis module 250 causes the patient sample tobe tested through the addition of conjugates and substrates forfluorescence and luminescence within optics box 10, and then analyzesthe results to determine whether the test yielded a positive or negativeresult. As described above, a positive result determined by optics box10 for a mixture of capture reagents indicates a positive result for atleast one of the capture reagents in the mixture, whereas a negativeresult determined by optics box 10 for a mixture of capture reagentsconclusively indicates that the patient sample did not test positive forany one of the capture reagents in the mixture. Analysis module 250therefore analyzes the results of the test to determine whether it canconclusively determine the results of the test with respect to eachcapture reagent in the mixture.

If the test result is negative for the mixture, analysis module 250determines that the patient sample tested negative for each capturereagent in the mixture, and communicates with reporting module 260 viacommunications module 270 so that reporting module 260 can process theresults and report the results to the user via GUI 30 or anotherreporting mechanism. If the test result is positive for the mixture,analysis module 250 determines whether the positive result can beattributed to a particular capture reagent within the mixture, orwhether any particular capture reagent in the mixture can be ruled outas causing the positive result. If analysis module 250 can conclusivelydetermine that each capture reagent of the combination either caused thepositive result or could not have caused the positive result, analysismodule 250 communicates with reporting module 260 via communicationsmodule 270 so that reporting module 260 can process the results andreport the results to the user via GUI 30 or another reportingmechanism.

If analysis module 250 cannot conclusively determine that each capturereagent of the combination either caused the positive result or couldnot have caused the positive result, then analysis module 250 can eitherbreak down the mixture of capture reagents into subgroups, or test eachindividual capture reagent separately, depending on how many capturereagents are in the combination or how many capture reagents could haveyielded the positive result. In an embodiment, analysis module 250communicates with inventory tracking module 230 while breaking down themixture into subgroups or individual capture reagents to ensure thatthat there is enough inventory for the further testing. In anotherembodiment, analysis module 250 breaks down the mixture of capturereagents based on the remaining inventory. For example, if there is onlyenough of a capture reagent to run one more test, analysis module 250may choose to test that capture reagent individually rather than riskanother inconclusive test.

Once analysis module 250 has determined how the subsequent testing is tobe performed, analysis module 250 communicates the subsequent testing tomixing module 240 via communications module 270 so that mixing module240 can prepare a new mixture or new individual samples. Mixing module240 can again communicate with inventory tracking module 230 viacommunications module 270 to communicate the subsequent testing toinventory tracking module 230, confirm that each of the necessarycapture reagents is available for use, and receive the exact location ofeach of the selected capture reagents for aspiration by R1 pipettor 4.Once the selected capture reagents have been mixed and incubated so thatthe analytes of interest in the patient's blood sample are bound to thecapture reagent that has in turn been bound to the surface of aparamagnetic particle, analysis module 250 again causes the patientsample to be tested through the addition of conjugates and substratesfor fluorescence and luminescence within optics box 10, and thenanalyzes the results to determine whether the test yielded a positive ornegative result. Analysis module 250 then either determines thatadditional testing should take place or that reporting module 260 canprocess the final results and report the results to the user via GUI 30or another reporting mechanism.

Disclosed herein are methods and systems for testing of patient sampleswith combinations of capture reagents. In alternative embodiments, thecombination includes two to twelve capture reagents. In otherembodiments, the combination includes three or more capture reagents,four or more capture reagents, five or more capture reagents, six ormore capture reagents. In yet other embodiments, the combinationincludes three capture reagents, four capture reagents, five capturereagents, six capture reagents, seven capture reagents, eight capturereagents, nine capture reagents, or ten capture reagents.

In some embodiments, the systems described herein can include anauto-reflexing function. The auto-reflexing function uses a processor toaccess a program stored in memory that if an answer a test comes backpositive, the system can alert a user that assays for individualanalytes in the sample may be desired. In other embodiments, uponreceiving a positive result, the system can automatically assay forindividual analytes in the sample. Automatically can me without userintervention. In other embodiments, user intervention may be requiredprior to running further tests on individual analytes.

In other embodiments, the positive or negative results described hereincan be qualitative or quantitative. In some embodiments, results may bea simply positive (e.g., true) or negative (e.g., false) based onpre-determined criterion. In other embodiments, results may be aparticular value that is then scaled or determined to be positive ornegative depending on pre-determined criterion.

Further, logic steps described herein can be completed by a user or oneor more processor that is executing instructions stored in memory.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

Unless otherwise indicated, all numbers expressing quantities ofingredients, properties such as molecular weight, reaction conditions,and so forth used in the specification and claims are to be understoodas being modified in all instances by the term “about.” Accordingly,unless indicated to the contrary, the numerical parameters set forth inthe following specification and attached claims are approximations thatmay vary depending upon the desired properties sought to be obtained bythe present disclosure. At the very least, and not as an attempt tolimit the application of the doctrine of equivalents to the scope of theclaims, each numerical parameter should at least be construed in lightof the number of reported significant digits and by applying ordinaryrounding techniques. Notwithstanding that the numerical ranges andparameters setting forth the broad scope of the disclosure areapproximations, the numerical values set forth in the specific examplesare reported as precisely as possible. Any numerical value, however,inherently contains certain errors necessarily resulting from thestandard deviation found in their respective testing measurements.

The terms “a” and “an” and “the” and similar referents used in thecontext of the disclosure (especially in the context of the followingclaims) are to be construed to cover both the singular and the plural,unless otherwise indicated herein or clearly contradicted by context.Recitation of ranges of values herein is merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range. Unless otherwise indicated herein, eachindividual value is incorporated into the specification as if it wereindividually recited herein. All methods described herein can beperformed in any suitable order unless otherwise indicated herein orotherwise clearly contradicted by context. The use of any and allexamples, or exemplary language (e.g. “such as”) provided herein isintended merely to better illuminate the disclosure and does not pose alimitation on the scope of the disclosure otherwise claimed. No languagein the specification should be construed as indicating any non-claimedelement essential to the practice of the disclosure.

The use of the term “or” in the claims is used to mean “and/or” unlessexplicitly indicated to refer to alternatives only or the alternativesare mutually exclusive, although the disclosure supports a definitionthat refers to only alternatives and “and/or.”

Groupings of alternative elements or embodiments of the disclosuredisclosed herein are not to be construed as limitations. Each groupmember may be referred to and claimed individually or in any combinationwith other members of the group or other elements found herein. It isanticipated that one or more members of a group may be included in, ordeleted from, a group for reasons of convenience and/or patentability.When any such inclusion or deletion occurs, the specification is hereindeemed to contain the group as modified thus fulfilling the writtendescription of all Markush groups used in the appended claims.

Preferred embodiments of the disclosure are described herein, includingthe best mode known to the inventors for carrying out the disclosure. Ofcourse, variations on those preferred embodiments will become apparentto those of ordinary skill in the art upon reading the foregoingdescription. The inventor expects those of ordinary skill in the art toemploy such variations as appropriate, and the inventors intend for thedisclosure to be practiced otherwise than specifically described herein.Accordingly, this disclosure includes all modifications and equivalentsof the subject matter recited in the claims appended hereto as permittedby applicable law. Moreover, any combination of the above-describedelements in all possible variations thereof is encompassed by thedisclosure unless otherwise indicated herein or otherwise clearlycontradicted by context.

Specific embodiments disclosed herein may be further limited in theclaims using consisting of or consisting essentially of language. Whenused in the claims, whether as filed or added per amendment, thetransition term “consisting of” excludes any element, step, oringredient not specified in the claims. The transition term “consistingessentially of” limits the scope of a claim to the specified materialsor steps and those that do not materially affect the basic and novelcharacteristic(s). Embodiments of the disclosure so claimed areinherently or expressly described and enabled herein.

Further, it is to be understood that the embodiments of the disclosuredisclosed herein are illustrative of the principles of the presentdisclosure. Other modifications that may be employed are within thescope of the disclosure. Thus, by way of example, but not of limitation,alternative configurations of the present disclosure may be utilized inaccordance with the teachings herein. Accordingly, the presentdisclosure is not limited to that precisely as shown and described.

1. A system for identifying allergens in patient samples, the systemcomprising: an automated immunochemistry analyzer configured to store aplurality of capture reagents in a reagent rotor; a memory devicestoring for each of the plurality of capture reagents, a name andcross-reactivity interference information in relation to other capturereagents; a user interface configured to display information to a userand receive inputs made by the user; and a logic implementercommunicatively coupled to the an automated immunochemistry analyzer,the memory device, and the user interface, the logic implementerconfigured to: receive, from the user interface, a selection to create asolid phase for identifying allergens within at least one patientsample, cause the user interface to display information indicative ofthe plurality of capture reagents, receive, from the user interface, afirst capture reagent selection identifying a first capture reagent ofthe plurality of capture reagents, use the cross-reactivity interferenceinformation of the first capture reagent to determine a second pluralityof capture reagents that can be combined with the first capture reagent,the second plurality of reagents being a subset of the plurality ofcapture reagents, cause the user interface to display informationindicative of the second plurality of capture reagents, receive, fromthe user interface, a second capture reagent selection identifying asecond capture reagent of the second plurality of capture reagents,receive, from the user interface, a selection finalization indicationfor the solid phase, and cause the automated immunochemistry analyzer toadd the first capture reagent and the second capture reagent to at leastone cuvette for identifying allergens within the at least one patientsample.
 2. The system of claim 1, wherein the logic implementer isfurther configured to: use the cross-reactivity interference informationof the first capture reagent and the second capture reagent to determinea third plurality of capture reagents that can be combined with thefirst capture reagent and the second capture reagent, the thirdplurality of reagents being a subset of the plurality of capturereagents; cause the user interface to display information indicative ofthe third plurality of capture reagents; receive, from the userinterface, a third capture reagent selection identifying a third capturereagent of the third plurality of capture reagents; and cause theautomated immunochemistry analyzer to add the third capture reagent tothe at least one cuvette for identifying allergens within the at leastone sample.
 3. The system of claim 1, wherein the automatedimmunochemistry analyzer is configured to store a container offluo-beads, and wherein the logic implementer is further configured to:determine an amount of the fluo-beads that is needed based on the firstcapture reagent and the second capture reagent, and cause the automatedimmunochemistry analyzer to add the determined amount of the fluo-beadsto the at least one cuvette.
 4. The system of claim 1, wherein thememory device stores for each of the plurality of capture reagents, anallergy class and an allergy subclass.
 5. The system of claim 4, whereinthe allergy subclass includes at least one of a grass allergy, a moldallergy, or an environmental allergy.
 6. The system of claim 1, whereinthe logic implementer is further configured to: receive, from the userinterface, a save command; and cause a solid phrase profile to be storedto the memory device, the solid phase profile including informationindicative of the first capture reagent and the second capture reagent.7. The system of claim 1, wherein the user interface and the logicimplementer are included within the automated immunochemistry analyzer.8. The system of claim 1, wherein the user interface and the logicimplementer are separate from and communicatively coupled to theautomated immunochemistry analyzer via a wireless or wired dataconnection.
 9. The system of claim 1, wherein the memory device storesfor each of the plurality of capture reagents, an amount of the capturereagent that is currently held within the reagent rotor.
 10. The systemof claim 9, wherein the logic implementer is further configured to:determine, as omitted capture reagents, which of the plurality ofcapture reagents in the reagent rotor have volumes that are less thanvolumes needed for the solid phase; and remove the omitted capturereagents from the information indicative of plurality of capturereagents that is displayed by the user interface.
 11. The system ofclaim 10, wherein the logic implementer is further configured to atleast one of: cause the user interface to display an indication of theomitted capture reagents; or cause the user interface to display aninstruction to refill the omitted capture reagents in the reagent rotor.12. A system for identifying allergens in patient samples, the systemcomprising: an automated immunochemistry analyzer configured to storecapture reagents in a reagent rotor; a memory device storing for each ofthe capture reagents, a name, cross-reactivity interference informationin relation to other capture reagents, and allergy class/subclassinformation; a user interface configured to display information to auser and receive inputs made by the user; and a logic implementercommunicatively coupled to the an automated immunochemistry analyzer,the memory device, and the user interface, the logic implementerconfigured to: receive, from the user interface, a selection to create asolid phase by identifying at least one allergy class/subclass foridentifying allergens within at least one patient sample, determine aplurality of capture reagents, of the capture reagents stored in theautomated immunochemistry analyzer, that provide for determination ofthe at least one allergy class/subclass using the allergy class/subclassinformation, cause the user interface to display information indicativeof the plurality of capture reagents, receive, from the user interface,a first capture reagent selection identifying a first capture reagent ofthe plurality of capture reagents, use the cross-reactivity interferenceinformation of the first capture reagent to determine a second pluralityof capture reagents that can be combined with the first capture reagent,the second plurality of reagents being a subset of the plurality ofcapture reagents, cause the user interface to display informationindicative of the second plurality of capture reagents, receive, fromthe user interface, a second capture reagent selection identifying asecond capture reagent of the second plurality of capture reagents,receive, from the user interface, a selection finalization indicationfor the solid phase, and cause the automated immunochemistry analyzer toadd the first capture reagent and the second capture reagent to at leastone cuvette for identifying allergens within the at least one patientsample.
 13. The system of claim 12, wherein the allergy class/subclassinformation includes at least one of a grass allergy, a mold allergy, oran environmental allergy.
 14. The system of claim 12, wherein the userinterface and the logic implementer are at least one of (i) includedwithin the automated immunochemistry analyzer, or (ii) separate from andcommunicatively coupled to the automated immunochemistry analyzer via awireless or wired data connection.
 15. The system of claim 12, whereinthe automated immunochemistry analyzer is configured to store acontainer of fluo-beads, and wherein the logic implementer is furtherconfigured to: determine an amount of the fluo-beads that is neededbased on the first capture reagent and the second capture reagent, andcause the automated immunochemistry analyzer to add the determinedamount of the fluo-beads to the at least one cuvette.
 16. A system foridentifying allergens in patient samples, the system comprising: anautomated immunochemistry analyzer configured to store capture reagentsin a reagent rotor; a memory device storing (i) a relationship betweenallergy classes/subclasses and at least one patient symptom, and (ii)for each of the capture reagents, a name, cross-reactivity interferenceinformation in relation to other capture reagents, and allergyclass/subclass information; a user interface configured to displayinformation to a user and receive inputs made by the user; and a logicimplementer communicatively coupled to the an automated immunochemistryanalyzer, the memory device, and the user interface, the logicimplementer configured to: receive, from the user interface, an inputindicative of at least one patient symptom for creating a solid phase toidentify allergens within at least one patient sample, determine atleast one allergy class/subclass that corresponds to the inputindicative of at least one patient symptom using (i). determine aplurality of capture reagents, of the capture reagents stored in theautomated immunochemistry analyzer, that provide for determination ofthe at least one allergy class/subclass using (ii), cause the userinterface to display information indicative of the plurality of capturereagents as a suggested combination of capture reagents, receive, fromthe user interface, a selection finalization indication for the solidphase, and cause the automated immunochemistry analyzer to add theplurality of capture reagents to at least one cuvette for identifyingallergens within the at least one patient sample.
 17. The system ofclaim 16, wherein the allergy class/subclass information includes atleast one of a grass allergy, a mold allergy, or an environmentalallergy.
 18. The system of claim 16, wherein the logic implementer isfurther configured to: receive, from the user interface, a first capturereagent selection identifying a first capture reagent of the pluralityof capture reagents; use the cross-reactivity interference informationof the first capture reagent to determine a second plurality of capturereagents that can be combined with the first capture reagent, the secondplurality of reagents being a subset of the plurality of capturereagents; cause the user interface to display information indicative ofthe second plurality of capture reagents; receive, from the userinterface, a second capture reagent selection identifying a secondcapture reagent of the second plurality of capture reagents; receive,from the user interface, the selection finalization indication for thesolid phase after the selection of the first and second capturereagents; and cause the automated immunochemistry analyzer to add theplurality of capture reagents by adding the first capture reagent andthe second capture reagent to the at least one cuvette for identifyingallergens within the at least one sample.
 19. The system of claim 16,wherein the automated immunochemistry analyzer is configured to store acontainer of fluo-beads, and wherein the logic implementer is furtherconfigured to: determine an amount of the fluo-beads that is neededbased on the plurality of capture reagents, and cause the automatedimmunochemistry analyzer to add the determined amount of the fluo-beadsto the at least one cuvette.
 20. The system of claim 16, wherein thememory device stores for each of the plurality of capture reagents, anamount of the capture reagent that is currently held within the reagentrotor, and wherein the logic implementer is further configured to:determine, as omitted capture reagents, which of the plurality ofcapture reagents in the reagent rotor have volumes that are less thanvolumes needed for the solid phase; and remove the omitted capturereagents from the information indicative of plurality of capturereagents that is displayed by the user interface.